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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Headquartered in India, Strides Pharma Science Limited is a pharmaceutical company with a major focus on the development and manufacture of IP-led niche finished dosage formulations. It is also among the world's largest manufacturers of soft gelatin capsules. With world-class manufacturing facilities, an innovative R&D hub in Bangalore and a robust commercial platform to market products globally, Strides has earned a reputation for building and scaling profitable businesses in a short span of time.

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India
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Strides House, Bilekahalli, Bannerghatta Road, Bangalore – 560076
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+91 8067840000
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    https://www.pharmacompass.com/pdf/party/content/strides-pharma-science-party-content-34447.pdf

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DATA COMPILATION #PharmaFlow

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Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities
Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 

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https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities

#PharmaFlow by PHARMACOMPASS
21 Nov 2024

NEWS #PharmaBuzz

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Chttps://strides.com/pdf/pressrelease/2025/StridesSEIntimation_signed_14_Mar_2025.pdf

PRESS RELEASE
18 Mar 2025

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-12-2025-94329.pdf

FDA
12 Feb 2025

https://strides.com/pdf/pressrelease/2025/newspaper_ad_31_jan_2025.pdf

PRESS RELEASE
31 Jan 2025

https://strides.com/pdf/pressrelease/2025/StridesSEIntimation_22Jan_2025.pdf

PRESS RELEASE
23 Jan 2025

https://strides.com/pdf/pressrelease/2025/StridesSEIntimation_22Jan_2025.pdf

PRESS RELEASE
22 Jan 2025

https://www.expresspharma.in/strides-gains-usfda-approval-for-acetaminophen-and-ibuprofen-tablets-125-mg-250-mg/

EXPRESSPHARMA
20 Jan 2025

Drugs in Development

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Details:

The company has received approval from the US Food and Drug Administration (USFDA) for generic version for Acetaminophen and Ibuprofen tablets (250 mg/125 mg) indicated for pain and inflammation.


Lead Product(s): Ibuprofen,Paracetamol

Therapeutic Area: Neurology Brand Name: Advil Dual Action

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 20, 2025

Strides Pharma Science

01

ASPEN
Not Confirmed

Lead Product(s) : Ibuprofen,Paracetamol

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : The company has received approval from the US Food and Drug Administration (USFDA) for generic version for Acetaminophen and Ibuprofen tablets (250 mg/125 mg) indicated for pain and inflammation.

Product Name : Advil Dual Action

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 20, 2025

Strides Pharma Science

Details:

Fluoxetine hydrochloride, is an antidepressant of the SSRIs class. It is used for the treatment of major depressive disorder, obsessive–compulsive disorder, bulimia nervosa, etc.


Lead Product(s): Fluoxetine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Fluoxetine HCl-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 18, 2024

Strides Pharma Science

02

ASPEN
Not Confirmed

Lead Product(s) : Fluoxetine Hydrochloride

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Fluoxetine hydrochloride, is an antidepressant of the SSRIs class. It is used for the treatment of major depressive disorder, obsessive–compulsive disorder, bulimia nervosa, etc.

Product Name : Fluoxetine HCl-Generic

Product Type : Small molecule

Upfront Cash : Not Applicable

September 18, 2024

Strides Pharma Science

Details:

Theophylline extended-release tablets formulation approved for the use in the treatment of asthma and chronic obstructive pulmonary disease.


Lead Product(s): Theophylline

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Theo-Dur-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 07, 2024

Strides Pharma Science

03

ASPEN
Not Confirmed

Lead Product(s) : Theophylline

Therapeutic Area : Pulmonary/Respiratory Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Theophylline extended-release tablets formulation approved for the use in the treatment of asthma and chronic obstructive pulmonary disease.

Product Name : Theo-Dur-Generic

Product Type : Small molecule

Upfront Cash : Not Applicable

September 07, 2024

Strides Pharma Science

Details:

Carafate-generic (sucralfate) is a USFDA approved pepsin A inhibitor small molecule drug candidate, which is indicated for the treatment of active duodenal ulcer.


Lead Product(s): Sucralfate

Therapeutic Area: Gastroenterology Brand Name: Carafate-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 23, 2024

Strides Pharma Science

04

ASPEN
Not Confirmed

Lead Product(s) : Sucralfate

Therapeutic Area : Gastroenterology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Carafate-generic (sucralfate) is a USFDA approved pepsin A inhibitor small molecule drug candidate, which is indicated for the treatment of active duodenal ulcer.

Product Name : Carafate-Generic

Product Type : Small molecule

Upfront Cash : Not Applicable

May 23, 2024

Strides Pharma Science

Details:

USFDA approved generic version of Sevelamer Carbonate which is used to manage elevated levels of phosphate in the blood of patients with chronic kidney disease.


Lead Product(s): Sevelamer Hydrochloride

Therapeutic Area: Nephrology Brand Name: Renvela-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 10, 2024

Strides Pharma Science

05

ASPEN
Not Confirmed

Lead Product(s) : Sevelamer Hydrochloride

Therapeutic Area : Nephrology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : USFDA approved generic version of Sevelamer Carbonate which is used to manage elevated levels of phosphate in the blood of patients with chronic kidney disease.

Product Name : Renvela-Generic

Product Type : Small molecule

Upfront Cash : Not Applicable

May 10, 2024

Strides Pharma Science

Details:

Fluoxetine hydrochloride (Prozac) is an SSRI antidepressant used for major depressive disorder, OCD, bulimia, and panic disorder.


Lead Product(s): Fluoxetine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Prozac-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 08, 2024

Strides Pharma Science

06

ASPEN
Not Confirmed

Lead Product(s) : Fluoxetine Hydrochloride

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Fluoxetine hydrochloride (Prozac) is an SSRI antidepressant used for major depressive disorder, OCD, bulimia, and panic disorder.

Product Name : Prozac-Generic

Product Type : Small molecule

Upfront Cash : Not Applicable

April 08, 2024

Strides Pharma Science

Details:

USFDA approved generic version of Gabapentin tablet, which is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain.


Lead Product(s): Gabapentin

Therapeutic Area: Neurology Brand Name: Neurontin-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 05, 2024

Strides Pharma Science

07

ASPEN
Not Confirmed

Lead Product(s) : Gabapentin

Therapeutic Area : Neurology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : USFDA approved generic version of Gabapentin tablet, which is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain.

Product Name : Neurontin-Generic

Product Type : Small molecule

Upfront Cash : Not Applicable

March 05, 2024

Strides Pharma Science

Details:

USFDA approved generic version of Pregabalin treatment of fibromyalgia. It binds to the alpha2-delta subunit which is involved in anti-nociceptive and antiseizure effects.


Lead Product(s): Pregabalin

Therapeutic Area: Musculoskeletal Brand Name: Lyrica-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 25, 2024

Strides Pharma Science

08

ASPEN
Not Confirmed

Lead Product(s) : Pregabalin

Therapeutic Area : Musculoskeletal

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : USFDA approved generic version of Pregabalin treatment of fibromyalgia. It binds to the alpha2-delta subunit which is involved in anti-nociceptive and antiseizure effects.

Product Name : Lyrica-Generic

Product Type : Small molecule

Upfront Cash : Not Applicable

January 25, 2024

Strides Pharma Science

Details:

Vascepa-Generic (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.


Lead Product(s): Icosapent Ethyl

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vascepa-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Amneal Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 02, 2023

Strides Pharma Science

09

ASPEN
Not Confirmed

Lead Product(s) : Icosapent Ethyl

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Amneal Pharmaceuticals

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Vascepa-Generic (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.

Product Name : Vascepa-Generic

Product Type : Small molecule

Upfront Cash : Not Applicable

December 02, 2023

Strides Pharma Science

Details:

USFDA approved generic version of Levetiracetam for the treatment of seizures. It prevents seizure activity via the selective inhibition of hypersynchronized epileptiform burst firing without affecting normal neuronal transmission.


Lead Product(s): Levetiracetam

Therapeutic Area: Neurology Brand Name: Keppra-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 21, 2023

Strides Pharma Science

10

ASPEN
Not Confirmed

Lead Product(s) : Levetiracetam

Therapeutic Area : Neurology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : USFDA approved generic version of Levetiracetam for the treatment of seizures. It prevents seizure activity via the selective inhibition of hypersynchronized epileptiform burst firing without affecting normal neuronal transmission.

Product Name : Keppra-Generic

Product Type : Small molecule

Upfront Cash : Not Applicable

November 21, 2023

Strides Pharma Science
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FDA Orange Book

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01

Brand Name : ACARBOSE

Strides Pharma Science

Dosage Form : TABLET; ORAL

Proprietary Name : ACARBOSE

Dosage Strength : 25MG

Approval Date : 2011-07-27

Application Number : 90912

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

02

Brand Name : ACARBOSE

Strides Pharma Science

Dosage Form : TABLET; ORAL

Proprietary Name : ACARBOSE

Dosage Strength : 50MG

Approval Date : 2011-07-27

Application Number : 90912

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

03

Brand Name : ACARBOSE

Strides Pharma Science

Dosage Form : TABLET; ORAL

Proprietary Name : ACARBOSE

Dosage Strength : 100MG

Approval Date : 2011-07-27

Application Number : 90912

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

04

Brand Name : BUTALBITAL, ACETAMIN...

Strides Pharma Science

Dosage Form : TABLET; ORAL

Proprietary Name : BUTALBITAL, ACETAMINOPHE...

Dosage Strength : 325MG;50MG;40MG

Approval Date : 2003-08-27

Application Number : 40511

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science

05

Brand Name : BUTALBITAL, ACETAMIN...

Strides Pharma Science

Dosage Form : TABLET; ORAL

Proprietary Name : BUTALBITAL, ACETAMINOPHE...

Dosage Strength : 325MG;50MG;40MG

Approval Date : 2020-09-21

Application Number : 203647

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science

06

Brand Name : BUTALBITAL, ACETAMIN...

Strides Pharma Science

Dosage Form : CAPSULE; ORAL

Proprietary Name : BUTALBITAL, ACETAMINOPHE...

Dosage Strength : 325MG;50MG;40MG;30MG

Approval Date : 2020-07-08

Application Number : 204649

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

07

Brand Name : ACETAMINOPHEN AND CO...

Strides Pharma Science

Dosage Form : SOLUTION; ORAL

Proprietary Name : ACETAMINOPHEN AND CODEIN...

Dosage Strength : 120MG/5ML;12MG/5ML

Approval Date : 1982-01-01

Application Number : 86366

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

08

Brand Name : ACETAMINOPHEN AND CO...

Strides Pharma Science

Dosage Form : TABLET; ORAL

Proprietary Name : ACETAMINOPHEN AND CODEIN...

Dosage Strength : 300MG;30MG

Approval Date : 1988-09-30

Application Number : 89805

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science

09

Brand Name : ACETAMINOPHEN AND CO...

Strides Pharma Science

Dosage Form : TABLET; ORAL

Proprietary Name : ACETAMINOPHEN AND CODEIN...

Dosage Strength : 300MG;60MG

Approval Date : 1988-09-30

Application Number : 89828

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science

10

Brand Name : ACETAMINOPHEN AND CO...

Strides Pharma Science

Dosage Form : TABLET; ORAL

Proprietary Name : ACETAMINOPHEN AND CODEIN...

Dosage Strength : 300MG;15MG

Approval Date : 1988-09-30

Application Number : 89990

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Strides Pharma Science
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KEY PRODUCTS

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